Study Details

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

This trial is recruiting
The study is currently recruiting participants.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04223856

Astellas Study ID

The unique identification code given by the study sponsor.

SGN22E-003

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2019-004542-15

Condition

Bladder Cancer

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Female & Male

Product

enfortumab vedotin

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2020 - Sep 2027

Masking

None (Open Label)

Enrollment number

990

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Study summary

Get More Information

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Locations

Maine Health Cancer Care

Biddeford, United States, 04046

Recruitment Complete

Georgia Cancer Specialists / Northside Hospital Cancer Institute

Marietta, United States, 30060

Study Complete

Vidant Medical Center

Greenville, United States, 27834

Recruitment Complete

Cancer Centers of Colorado - Denver

Denver, United States, 80218

Recruitment Complete

Mount Sinai Medical Center

New York, United States, 10029

Recruitment Complete

Johns Hopkins Medical Center

Baltimore, United States, 21231

Recruitment Complete

Rocky Mountain Cancer Centers - Aurora

Aurora, United States, 80012

Recruitment Complete

University of Colorado Hospital / University of Colorado

Aurora, United States, 80045

Recruitment Complete

UT Health East Texas Hope Cancer Center

Tyler, United States, 75701

Recruitment Complete

Winship Cancer Institute / Emory University School of Medicine

Atlanta, United States, 30322

Study Complete

Toledo Clinic Cancer Center

Toledo, United States, 43623

Study Complete

The Cleveland Clinic

Cleveland, United States, 44195

Recruitment Complete

Arizona Oncology Associates PD - HOPE

Tucson, United States, 85710

Study Complete

Ironwood Cancer & Research Centers - Chandler

Chandler, United States, 85224

Study Complete

City of Hope National Medical Center

Duarte, United States, 91010

Recruitment Complete

H. Lee Moffitt Cancer Center and Research Institute

Tampa, United States, 33612

Study Complete

Comprehensive Cancer Centers of Nevada

Las Vegas, United States, 89169

Recruitment Complete

University of Virginia

Charlottesville, United States, 22908

Recruitment Complete

Lombardi Cancer Center / Georgetown University Medical Center

Washington, United States, 20007

Recruitment Complete

Louisiana State University/ East Jefferson General Hospital

Metairie, United States, 70006

Study Complete

West Cancer Center & Research Institute

Germantown, United States, 38138

Study Complete

New Mexico Cancer Center

Albuquerque, United States, 87109

Recruitment Complete

University of Texas Southwestern Medical Center

Dallas, United States, 75390

Recruitment Complete

Seattle Cancer Care Alliance / University of Washington

Seattle, United States, 98109

Recruitment Complete

Saint Francis Hospital / Bon Secours - South Carolina

Greenville, United States, 29607

Study Complete

Hillman Cancer Center / University of Pittsburgh Medical Center

Pittsburgh, United States, 15232

Study Complete

University of California Irvine - Newport

Orange, United States, 92868

Recruitment Complete

Huntsman Cancer Institute

Salt Lake City, United States, 84112

Recruitment Complete

Memorial Sloan Kettering Cancer Center

New York, United States, 10065

Recruitment Complete

Eastern CT Hematology and Oncology Associates

Norwich, United States, 06360

Recruitment Complete

Providence St Joseph Medical Center

Burbank, United States, 91505

Study Complete

University of California Los Angeles Medical Center

Los Angeles, United States, 90095

Recruitment Complete

Site CA11001

Montreal, Canada, H3T 1E2

Recruitment Complete

Site CA11003

Edmonton, Canada, T6G 1Z2

Recruitment Complete

Site ES34002

Madrid, Spain, 28034

Recruitment Complete

Site ES34004

Manresa, Spain, 08243

Recruitment Complete

Site ES34007

Sevilla, Spain, 41013

Recruitment Complete

Site ES34010

Barcelona, Spain, 08035

Recruitment Complete

Site ES34020

Pamplona, Spain, 31008

Recruitment Complete

Site KR82008

Hwasun, Republic of Korea, 519-763

Recruitment Complete

Site CA11009

London, Canada, N6A 5A5

Recruitment Complete

Site AUS61006

South Australia, Australia, 5112

Recruitment Complete

Site AUS61002

Macquarie Park, Australia, 2109

Recruitment Complete

Site CA11008

Quebec, Canada, G1R 2J6

Recruitment Complete

Site CA11011

Oshawa, Canada, L1G 2B9

Recruitment Complete

Site ES34016

Sabadell, Spain, 08208

Recruitment Complete

Site ES34017

Barcelona, Spain, 08003

Recruitment Complete

Site ES34001

Barcelona, Spain, 08041

Recruitment Complete

Site ES34012

Santander, Spain, 39008

Recruitment Complete

Site CA11005

Toronto, Canada, M5G 2M9

Recruitment Complete

Site CA11004

Calgary, Canada, T2N 4N2

Recruitment Complete

Site CA11006

Vancouver, Canada, V5Z 4E6

Recruitment Complete

Site CA11010

Montreal, Canada, H2X 0A9

Recruitment Complete

Site AUS61004

Heidelberg, Australia, 3084

Recruitment Complete

Site AUS61001

Douglas, Australia, 4814

Recruitment Complete

Site FR33016

Lyon, France, 69373

Recruitment Complete

Site RU70002

Omsk, Russian Federation, 644013

Recruitment Complete

Site RU70010

Saint Petersburg, Russian Federation, 195271

Recruitment Complete

Site RU70007

Saint Petersburg, Russian Federation, 197082

Recruitment Complete

Site RU70005

Ufa, Russian Federation, 450000

Site RU70006

Leningradskaya oblast', Russian Federation, 188663

Recruitment Complete

Site KR82001

Daejeon, Republic of Korea, 301-721

Recruitment Complete

Site KR82002

Goyang-si, Republic of Korea, 10408

Recruitment Complete

Site KR82003

Seoul, Republic of Korea, 03722

Recruitment Complete

Site KR82004

Seongnam-si, Republic of Korea, 13605

Recruitment Complete

Site KR82007

Seoul, Republic of Korea, 135-710

Recruitment Complete

Site ES34013

Cordoba, Spain, 14004

Recruitment Complete

Site CH41002

Bern, Switzerland, 3010

Recruitment Complete

Site CH41001

Chur, Switzerland, 7000

Recruitment Complete

Site CH41003

Winterthur, Switzerland, 8401

Recruitment Complete

Site TW88607

Taichung, Taiwan, Province of China, 40447

Recruitment Complete

Site TW88601

Taipei, Taiwan, Province of China, 11217

Recruitment Complete

Site TW88604

Tainan, Taiwan, Province of China, 70403

Recruitment Complete

Site TW88605

Taipei, Taiwan, Province of China, 10002

Recruitment Complete

New York University (NYU) Cancer Institute

New York, United States, 10016

Recruitment Complete

Site CA11002

Hamilton, Canada, L8V 1C3

Recruitment Complete

Site NL31002

Amsterdam, Netherlands, 1066 CX

Recruitment Complete

Site NL31004

Nieuwegein, Netherlands, 3435 CM

Recruitment Complete

Site NL31006

Utrecht, Netherlands, 3584 CX

Recruitment Complete

Site BE32001

Liege, Belgium, 4000

Recruitment Complete

Site BE32002

Ghent, Belgium, 9000

Recruitment Complete

Site BE32003

Brussels, Belgium, 1200

Recruitment Complete

Site BE32006

Roeselare, Belgium, 8800

Recruitment Complete

Site ES34019

Valencia, Spain, 46009

Recruitment Complete

Site ES34021

Lugo, Spain, 27003

Recruitment Complete

Site HU36001

Nyiregyhaza, Hungary, 4400

Study Complete

Site HU36002

Budapest, Hungary, 1122

Recruitment Complete

Site IT39002

Terni, Italy, 05100

Recruitment Complete

Site IT39006

Genova, Italy, 16132

Recruitment Complete

Site DE49004

Tübingen, Germany, 72076

Recruitment Complete

Site DE49007

Frankfurt am Main, Germany, 60488

Recruitment Complete

Site DE49013

Bielefeld, Germany, 33611

Recruitment Complete

Site AU61003

Box Hill, Australia, 3128

Recruitment Complete

Site RU70003

Moscow, Russian Federation, 125284

Recruitment Complete

Site RU70009

Saransk, Russian Federation, 430032

Recruitment Complete

Site RU70013

Barnaul, Russian Federation, 656049

Recruitment Complete

Site RU70014

Krasnoyarsk, Russian Federation, 660133

Site RU70016

Arkhangelsk, Russian Federation, 163045

Recruitment Complete

Site JP81001

Koto-ku, Japan

Recruitment Complete

Site JP81002

Bunkyo City, Japan

Recruitment Complete

Site JP81003

Toyama, Japan

Study Complete

Site JP81004

Tsukuba, Japan

Recruitment Complete

Site JP81006

Kawasaki-shi, Japan

Recruitment Complete

Site KR82005

Seoul, Republic of Korea, 05505

Recruitment Complete

Site KR82006

Seoul, Republic of Korea, 137-701

Recruitment Complete

Site TW88606

Taichung, Taiwan, Province of China, 40705

Recruitment Complete

Site JP81005

Okayama, Japan

Recruitment Complete

Site RU70011

Moscow, Russian Federation, 123056

Recruitment Complete

Site JP81009

Chiba, Japan

Recruitment Complete

Site IT39001

Verona, Italy, 37134

Recruitment Complete

Site NL31005

Amsterdam, Noord-Holland, Netherlands, 1066 CX

Recruitment Complete

Site IT39004

Pisa, Italy, 56126

Recruitment Complete

Yale Cancer Center

New Haven, United States, 06520

Recruitment Complete

Site IT39005

Areezo, Italy, 52100

Recruitment Complete

Site DK45001

Aalborg, Denmark, 9100

Recruitment Complete

Site FR33011

Villejuif-Cedex-France, France, 94805

Recruitment Complete

Site IT39008

Candiolo, Italy, 10060

Study Complete

Site NL31007

Leeuwarden, Netherlands, 8934 AD

Recruitment Complete

Site UK44001

London, United Kingdom, EC1M 6BQ

Recruitment Complete

Site UK44002

Preston, United Kingdom, PR2 9HT

Recruitment Complete

Site CA11012

Toronto, Canada, M4N 3M5

Recruitment Complete

Site ES34008

Barcelona, Spain, 08907

Recruitment Complete

Site AU61005

South Brisbane, Australia, 4101

Recruitment Complete

Site BE32007

Lueven, Belgium, 3000

Recruitment Complete

Site DE49002

Munchen, Germany, 81675

Recruitment Complete

Site DE49010

Ulm, Germany, 89081

Recruitment Complete

Site DE49011

Essen, Germany, 45147

Recruitment Complete

Site DE49012

Mannheim, Germany, 68167

Recruitment Complete

Site ES34006

Barcelona, Spain, 08036

Recruitment Complete

Site ES34009

Valencia, Spain, 46014

Study Complete

Site ES34015

Madrid, Spain, 28041

Recruitment Complete

Site IT39003

Meldola, Italy, 47014

Recruitment Complete

Site IT39007

Milano, Italy, 20141

Recruitment Complete

Site IT39009

Cremona, Italy, 26100

Recruitment Complete

Site IT39011

Torrette, Italy, 60126

Recruitment Complete

Site JP81007

Sapporo, Japan

Recruitment Complete

Site JP81008

Osaka, Japan

Recruitment Complete

Site JP81010

Ube, Japan

Recruitment Complete

Site JP81016

Osakasayama-Shi, Japan

Recruitment Complete

Site JP81017

Kyoto, Japan

Recruitment Complete

Site JP81018

Chiba, Japan

Recruitment Complete

Site NL31001

Amsterdam, Netherlands, 1081 HV

Recruitment Complete

Site NL31003

Rotterdam, Netherlands, 3075 EA

Recruitment Complete

Site RU70012

Saint-Petersburg, Russian Federation, 197758

Recruitment Complete

Site SG65002

Singapore, Singapore, 169610

Recruitment Complete

Site TW88602

Kweishan, Taiwan, Province of China, 333

Recruitment Complete

Site UK44006

Oxford, United Kingdom, OX3 7LE

Recruitment Complete

Site DE49009

Herne, Germany, 44649

Recruitment Complete

Site JP81011

Hirosaki, Japan

Recruitment Complete

Site JP81019

Tokyo, Japan

Recruitment Complete

Site RU70004

Moscow, Russian Federation, 105077

Site UK44005

Glasgow, United Kingdom, G12 0YN

Recruitment Complete

Site JP81014

Tokushima, Japan

Recruitment Complete

Site JP81013

Fukuoka, Japan

Recruitment Complete

Site JP81012

Sendai-city, Japan

Recruitment Complete

Site JP81015

Niigata, Japan

Recruitment Complete

Site HU36005

Szolnok, Hungary, 5004

Recruitment Complete

Site HU36006

Debrecen, Hungary, 4032

Recruitment Complete

Site JP81020

Fukuoka, Japan

Recruitment Complete

Site RU70008

St. Petersburg, Russian Federation, 197758

Site RU70015

Tyumen, Russian Federation, 625041

Recruitment Complete

Site RU70020

Ivanovo, Russian Federation, 153040

Recruitment Complete

Site SG65003

Singapore, Singapore, 308433

Recruitment Complete

Site TR90001

Konya, Turkey, 42080

Recruitment Complete

Site TR90002

Istanbul, Turkey, 81450

Recruitment Complete

Site DE49005

Heidelberg, Germany, 69120

Recruitment Complete

Site RU70017

Nizhniy Novgorod, Russian Federation, 603074

Recruitment Complete

Site TR90009

Ankara, Turkey, 6230

Recruitment Complete

Site UK44009

London, United Kingdom, W6 8RF

Recruitment Complete

Site AR54002

San Miguel, Argentina, T400GTB

Recruitment Complete

Site ES34018

Madrid, Spain, 28007

Study Complete

Site AR54008

Buenos Aire, Argentina, C1019ABS

Recruitment Complete

Site RU70019

Pyatigorsk, Russian Federation, 357502

Site AR54006

La Rioja, Argentina, 5300

Recruitment Complete

Site TW88603

Kaohsiung, Taiwan, Province of China, 83301

Recruitment Complete

Site TH66001

Ratchathewi, Thailand, 10400

Recruitment Complete

Site TH66002

HatYai, Thailand, 90110

Recruitment Complete

Site TH66003

Bangkok, Thailand, 10400

Recruitment Complete

Site TH66004

Bangkok, Thailand, 10330

Recruitment Complete

Site TH66005

Chiang Mai, Thailand, 50200

Recruitment Complete

Site TH66006

Krung Thep Maha Nakhon, Thailand, 10700

Recruitment Complete

Site TH66007

Muang, Thailand, 40002

Recruitment Complete

Site FR33013

Strasbourg, France, 67200

Study Complete

Site FR33014

Bordeaux, France, 33000

Recruitment Complete

Site AR54001

Rosario, Argentina, 2000

Recruitment Complete

Site CZ42001

Hradec Kralove, Czech Republic, 500 05

Recruitment Complete

Site DE49014

Erlangen, Germany, 91054

Study Complete

Site DE49016

Düsseldorf, Germany, 40225

Recruitment Complete

Site FR33003

Nice Cedex 2, France, 06189

Recruitment Complete

Site HU36003

Budapest, Hungary, 1083

Recruitment Complete

Site AR54012

Tucuman, Argentina, T4000IAK

Recruitment Complete

Site AR54003

Viedma, Argentina, 8500

Study Complete

Site DK45003

Aarhus N, Denmark, 8200

Recruitment Complete

Site IL97203

Beer Sheva, Israel, 84101

Recruitment Complete

Site IL97211

Rehovot, Israel, 76100

Study Complete

Site IL97204

Tel Hashomer, Israel, 52621

Recruitment Complete

Site IL97206

Jerusalem, Israel, 91120

Recruitment Complete

Site IL97201

Haifa, Israel, 31096

Recruitment Complete

Site IL97205

Zerifin, Israel, 70300

Study Complete

Site IL97208

Petach Tikva, Israel, 49414

Recruitment Complete

Site SG65001

Singapore, Singapore, 119074

Recruitment Complete

Site UK44003

Sheffield, United Kingdom, S10 2RX

Recruitment Complete

Site TR90007

Ankara, Turkey, 6100

Recruitment Complete

Site FR33017

TOURS Cedex 09, France, 37044

Recruitment Complete

Site CH41004

Basel, Switzerland, 4031

Study Complete

Site CZ42005

Praha 4-Krc, Czech Republic, 140 59

Recruitment Complete

Site DE49001

Lubeck, Germany, 23538

Recruitment Complete

Site DE49008

Magdeburg, Germany, 39120

Recruitment Complete

Site IL97202

Kfar Saba, Israel, 44281

Recruitment Complete

Site IL97209

Holon, Israel, 58100

Recruitment Complete

Site IL97210

Tel Aviv, Israel, 64239

Recruitment Complete

Site FR33020

Pierre-Bénite, France, 69495

Recruitment Complete

Site CZ42004

Olomouc, Czech Republic, 779 00

Recruitment Complete

Site CZ42006

Brno, Czech Republic, 656 91

Recruitment Complete

Site DE49003

Berlin, Germany, 10117

Recruitment Complete

Site TR90003

Istanbul, Turkey, 34214

Recruitment Complete

Site TR90008

Istanbul, Turkey, 34093

Recruitment Complete

Site UK44010

Plymouth, United Kingdom, PL6 8DH

Recruitment Complete

Site TR90005

Antalya, Turkey, 07059

Recruitment Complete

Site TR90006

Malatya, Turkey, 44280

Recruitment Complete

Site PL48002

Warszawa, Poland, 01-748

Recruitment Complete

Site UK44008

Southampton, United Kingdom, SO16 6YD

Recruitment Complete

Site CN86001

Beijing, China, 100036

Recruiting

Site AR54004

Mendoza, Argentina, M5500AYB

Study Complete

Site AR54005

Cordoba, Argentina, X5004FHP

Study Complete

Site AR54011

CABA, Argentina, C1426ANZ

Recruitment Complete

Site DE49006

Jena, Germany, 07747

Recruitment Complete

Site DE49015

Gottingen, Germany, 37099

Recruitment Complete

Site TR90004

Edirne, Turkey, 22030

Recruitment Complete

Site CN86004

Beijing, China, 100050

Recruiting

Site CN86005

Beijing, China, 100191

Recruiting

Site CN86017

Nanjing, China, 210008

Recruiting

Site IT39014

Milano, Italy, 20132

Recruitment Complete

Site ES34003

Madrid, Spain, 28040

Recruitment Complete

Site CN86013

Hangzhou, China, 310014

Recruiting

Site CN86015

Bengbu, China, 233000

Recruiting

Site CN86016

Changsha, China, 410013

Recruiting

Site CN86018

Hangzhou, China, 0571

Recruiting

Site CN86019

Tianjin, China, 453000

Recruiting

Site CN86003

Changchun, China, 130021

Recruiting

Site CN86007

Chongqing, China, 400038

Recruiting

Site CN86008

Wuhan City, China, 430030

Recruiting

Site CN86009

Beijing City, China, 100021

Recruiting

Site CN86011

Shenyang City, China, 110022

Recruiting

Site CN86014

Shanghai, China, 200040

Recruiting

Site CN86020

Gunagzhou, China, 510280

Recruiting

Site CN86023

Tianjin, China, 300052

Recruiting

Site CN86002

Guangzhou, China, 510120

Recruiting

Site CN86012

Nanjing, China, 210029

Recruiting

Site CN86027

Jinan, China, 250021

Recruiting

Site CN86029

Wenzhou, China, 325000

Recruiting

Site CN86026

Xuzhou, China, 221009

Recruiting

Site CN86030

Xicheng District, China, 100034

Recruiting

Site CN86022

Hangzhou, China, 310016

Recruiting

Site CN86021

Ningbo, China, 315016

Recruiting

Site CN86025

Hefei, China, 400030

Recruiting

Site CN86028

Fuzhou, China, 350005

Recruiting

Site CN86010

Chengdu, China, 610041

Recruiting

Site CN86024

Chongqing, China, 400030

Recruiting

Site CN86006

Changsha, China, 410013

Recruiting